INDICATIONS

Adjuvant Treatment

First-Line Treatment

ARIMIDEX is indicated for the
first-line treatment of postmenopausal women with hormone receptor-positive or
hormone receptor unknown locally advanced or metastatic breast cancer.

Second-Line Treatment

ARIMIDEX is indicated for the
treatment of advanced breast cancer in postmenopausal women with disease progression
following tamoxifen therapy. Patients with ER-negative disease and patients who
did not respond to previous tamoxifen therapy rarely responded to ARIMIDEX.

DOSAGE AND ADMINISTRATION

Recommended Dose

The dose of ARIMIDEX is one 1 mg tablet taken once a day.
For patients with advanced breast cancer, ARIMIDEX should be continued until
tumor progression. ARIMIDEX can be taken with or without food.

For adjuvant treatment of early breast cancer in
postmenopausal women, the optimal duration of therapy is unknown. In the ATAC
trial, ARIMIDEX was administered for five years [see Clinical Studies].

Patients With Hepatic Impairment

No changes in dose are recommended for patients with
mild-to-moderate hepatic impairment. ARIMIDEX has not been studied in patients
with severe hepatic impairment [seeUse in Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

The tablets are white, biconvex, film-coated containing 1
mg of anastrozole. The tablets are impressed on one side with a logo consisting
of a letter “A” (upper case) with an arrowhead attached to the foot of the
extended right leg of the “A” and on the reverse with the tablet strength
marking “Adx 1”.

Storage And Handling

These tablets are supplied in
bottles of 30 tablets (NDC 0310-0201-30).